It will be reviewed by the Regulatory Reform Committee

Conflict between the MFDS and pharmaceutical companies

Ministry's self-examination after administrative notice and opinion inquiry

Whether or not to introduce the "no change in manufacturing" policy of consignment generic, which is being opposed by the domestic pharmaceutical industry, will eventually be decided based on the results of the Regulatory Reform Committee review.

 

The MFDS finished collecting opinions on the related industries by March this year after announcing the regulations last year, began reviewing internal regulations, and even completed reporting to the president and the National Assembly.

 

On the 8th, the pharmaceutical industry is stressed by the MFDS' move to prevent pharmaceutical companies with consignment generics from changing manufacturing sources.

 

The MFDS has begun discussions such as the regulatory reform legal affairs office's own review of the Regulatory Reform Committee, which is necessary to introduce administrative regulations restricting changes to manufacturers.

 

Until just before the review of the Regulatory Reform Committee, work related to regulations on new and strengthened regulations has been carried out.

 

Regarding the reason for the introduction of the restriction on change of manufacturers, the MFDS explained, "It is to continuously improve the quality of medicines by strengthening the management of manufacturing methods such as the manufacturing process of Rx drugs." The MFDS said that "systematic management and international harmony are needed for changes in the manufacturing method of finished drugs that can affect the quality, safety and effectiveness of impurities." The KIPCO and the KPBMA are confronting the MFDS, saying that it is excessive and double regulation to prevent changes in manufacturers now that the "1+3 Restricted Act" has been introduced and implemented.

 

The reason why regulations against the domestic pharmaceutical industry have proceeded such as administrative notice, opinion check, and internal regulatory review by the Ministry of Food and Drug Safety was uncertain whether the pharmaceutical 1+3 restriction law could pass the National Assembly.

 

The 1+3 Act is a strong regulation that limits the number of marketing permits for generic and improved new drugs to four.

 

The pharmaceutical industry could not oppose the MFDS' plan to solve some problems of domestic generics by banning manufacturers from changing their manufacturers because it was uncertain whether the 1+3 law would pass the National Assembly.

 

The 1+3 Act was implemented to limit the number of commercial permits for new drugs as well as generics.

 

In response, the pharmaceutical industry is arguing that introducing restrictions on changes in manufacturing sources is excessive regulation and overlapping regulation.

 

In the end, it is expected that the regulation will be introduced in Korea based on the results of the Regulatory Reform Committee review.

 

It will review the MFDS' internal regulatory review and decide whether to implement or withdraw the objection.

 

An official from a local pharmaceutical company said, "The pharmaceutical companies are in conflict with the MFDS' position that prohibition of changes in manufacturing is excessive regulation and that no country in the world has freely released changes in manufacturing." "In particular, it was difficult for the pharmaceutical industry to oppose because it was unclear whether the 1+3 Act was passed by the National Assembly at the time of the administrative notice banning manufacturers from changing their sources," he explained.

 

He added, "Regulatory Reform Committee has also lifted restrictions on 1+3 by the MFDS, so it may decide to withdraw the ban on changing manufacturing sources." Meanwhile, the MFDS did not elaborate except that it was conducting an internal regulatory review in this regard.